Piqray Use In Pregnancy & Lactation

Fertility: There is no data on the effect of alpelisib on fertility. Based on repeat dose toxicity studies in animals, PIQRAY may impair fertility in males and females of reproductive potential.
Dedicated fertility studies were not conducted with alpelisib. In repeated-dose toxicity studies up to 13-weeks duration, adverse effects were observed in reproductive organs including vaginal epithelial atrophy, vaginal atrophy and oestrous cycle variations in rats at doses ≥2 mg/kg/day (0.1 times the exposure in humans at the recommended dose of 300 mg/day based on AUC), and decreased secretion in prostate and seminal vesicle in rats at ≥10 mg/kg/day (0.8 times the exposure in humans) and prostate glandular atrophy in dogs at 15 mg/kg/day (2.3 times the exposure in humans) and tubular degeneration/atrophy in the pilot study in dogs at ≥10 mg/kg/day (~1 times the exposure in humans).
Use in Pregnancy (Category D): Based on animal data and its mechanism of action, PIQRAY can cause fetal harm when administered to a pregnant woman.
There are no adequate and well-controlled studies in pregnant women. Embryo-fetal development studies in rats and rabbits have demonstrated that oral administration of alpelisib during organogenesis induced embryo-lethality, feto-toxicity, and teratogenicity. Increased incidences of post-implantation loss, reduced fetal weights, and increased incidences of fetal abnormalities were observed at 10 mg/kg/day in rats and 15 mg/kg/day in rabbits with systemic exposures 0.8 (rat) and 5 times (rabbit) the exposure in humans at the highest recommended dose of 300 mg/day based on AUC.
PIQRAY should not be used during pregnancy unless the benefits to the mother outweighs the risk to the fetus. If PIQRAY is used during pregnancy, the patient should be advised of the potential risk to the fetus.
Contraception: A negative pregnancy status for females of reproductive potential should be verified prior to starting treatment with PIQRAY.
Females of reproductive potential should be advised that animal studies and the mechanism of action have shown that alpelisib can be harmful to the developing fetus. Sexually-active females of reproductive potential should use effective contraception (methods that result in less than 1% pregnancy rates) when using PIQRAY during treatment and for at least 4 days after stopping treatment with alpelisib. It is currently unknown whether alpelisib may reduce the effectiveness of systemically acting hormonal contraceptives.
Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant should use condoms during sexual intercourse while taking PIQRAY and for at least 4 days after stopping treatment with PIQRAY.
Use in Lactation: It is not known if alpelisib is transferred into human or animal milk after administration of PIQRAY. There are no data on the effects of alpelisib on the breastfed child or the effects of alpelisib on milk production.
Because of the potential for serious adverse drug reactions in the breastfed child from PIQRAY, it is recommended that women should not breastfeed during treatment and for at least 4 days after the last dose of PIQRAY.